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Nellcor, Durasensor, Dura-Y, Max-Fast, OxiCliq, Oxiband, OxiMax, Oxinet, Pedi-Check, SatSeconds, OxiMax SPD Alert, and SoftCare are trademarks of Nellcor Puritan Bennett LLC.The OxiMax N-600x pulse oximeter is covered by one or more of the following U.S. patents and foreign equivalents: Patent No. 5,485,847; 5,676,141; 5,743,263; 6,035,223; 6,226,539; 6,411,833; 6,463,310; 6,591,123; 6,708,049; 7,016,715; 7,039,538; 7,120,479; 7,120,480; 7,142,142; 7,162,288; 7,190,985; 7,194,293; 7,209,774; 7,212,847, 7,400,919.To obtain information about a warranty, if any, contact Nellcors Technical Services Department at 1.800.635.5267 or your local representative.Purchase of this instrument confers no express or implied license under any Nellcor Puritan Bennett patent to use the instrument with any sensor that is not manufactured or licensed by Nellcor Puritan Bennett LLC.

N-600x Operators Manual i

C o n t e n t s

Contents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . i

Safety Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1Safety Warnings ................................................................................1Safety Cautions .................................................................................3

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5Intended Use .....................................................................................5How to Use this Manual ....................................................................6

Symbols, Controls, Displays and Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . 7About the Front Panel .......................................................................7About the Rear Panel ........................................................................8About the Symbols ............................................................................9About the Controls ..........................................................................10About the Displays ..........................................................................11

Pleth Display .........................................................................11Blip Display ..........................................................................12Real-Time Trend Display ......................................................14SpO2 and Pulse Rates .........................................................14

About the Visual Indicators .............................................................16About the Audible Indicators ...........................................................19

Setting Up the Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21List of Components .........................................................................23Connecting to an AC Power Source ...............................................24Connecting an OXIMAX Sensor ......................................................26

Operating the Battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27Operating on Battery Power ............................................................27Low Battery Indicator ......................................................................29

Description of Low and Critical Battery Conditions ...............30Battery Fuel Gauge Indicator ................................................34

Using the Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35Overview .........................................................................................35Menu Description ............................................................................35

Menu Structure .....................................................................36Parameter Ranges ..........................................................................40

Contents

ii

Turning On the Monitor ................................................................... 43OXIMAX Sensor Attached .................................................... 45No OXIMAX Sensor Attached .............................................. 48

Turning the Backlight On or Off ...................................................... 49Adjusting the Screen Contrast ........................................................ 49Adjusting the Backlight Brightness ................................................. 49Selecting the Pleth View ................................................................. 50Selecting the Blip View ................................................................... 50Selecting the Real-Time Trend View .............................................. 51

Selecting the Trend Data Display ......................................... 52Setting the Trend Time Scale Display .................................. 52Setting the Trend Amplitude Scale Display .......................... 53

Setting the Pulse Beep Volume ...................................................... 53Setting the Alarm Volume ............................................................... 54Setting the Date and Time .............................................................. 55Setting the Alarm Silence Duration ................................................. 57Disabling Audible Alarms ................................................................ 58Selecting the Standby Mode ........................................................... 59Adult-Pediatric or Neonatal Settings ............................................... 60

Setting Patient Adult-Pediatric or Neonatal Modes .............. 61Alarm Limit Changed Indicator ....................................................... 62Setting Alarm Limits ........................................................................ 62Setting SatSeconds Alarm Limit ..................................................... 64Setting Monitor Response Mode .................................................... 65Selecting the Display Language ..................................................... 67OXIMAX Sensor Messages ............................................................ 68

OXIMAX Sensor Adjust Condition Messages ....................... 69OXIMAX Sensor Adjust Messages ....................................... 70

Using Monitor Trend Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .71Overview ......................................................................................... 71

Storing Trend Data ............................................................... 73OXIMAX Sensor Type .................................................................... 74Selecting the Trend Data Display Scale ......................................... 74Reading the Trend Data Display ..................................................... 76Dual Trend Data Display ................................................................. 77SpO2 Trend Display ....................................................................... 78Pulse Rate Trend Display ............................................................... 78Histogram Trend Data Display ........................................................ 79Pulse Amplitude Trend Data Display .............................................. 80Clearing Trend Information ............................................................. 81

N-600x Operators Manual iii

Using OXIMAX Sensor Event Records . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83Overview .........................................................................................83Setting up OXIMAX Sensor Messages ...........................................85Setting In-Sensor Data Type ...........................................................86OXIMAX Sensor Data Type ............................................................87OXIMAX Sensor Event Record Data Available ...............................88OXIMAX Sensor Event Record Not Available .................................89OXIMAX Sensor Event Record Graphical Data ..............................90Viewing and Printing OXIMAX Sensor Event History Data .............92OXIMAX Sensor Tabular Event Data ..............................................94Viewing and Printing In-Sensor Tabular Event History Data ...........95

Printing Monitor Trend Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 97Overview .........................................................................................97

Printing ..................................................................................97Monitor Trend Data in ASCII Mode ...............................................100Trend Data in Graph Mode ...........................................................101Real-Time Display/Printout Format ...............................................101

Column Headings ...............................................................103Data Source ........................................................................103Software Version ................................................................104Alarm Limits ........................................................................104Monitor Mode ......................................................................104Response Mode ..................................................................105Data Column Headings .......................................................105Time ....................................................................................106Patient Data ........................................................................106Operating Status .................................................................106

Using the Data Port . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109Overview .......................................................................................109Connecting to the Data Port ..........................................................110

Data Port Pinouts ................................................................110Data Port Setup .............................................................................112Using the Nurse Call Interface ......................................................114

Setting Nurse Call RS-232 Polarity .....................................115Setting Nurse Call Relays Normally Open/Closed ..............116

Calculating the Analog Voltage Output .........................................116

OXIMAX Sensors and Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 119Overview .......................................................................................119Selecting an OXIMAX Sensor .......................................................120OXIMAX Sensor Features .............................................................124Biocompatibility Testing ................................................................124

Contents

iv

Optional Accessories .................................................................... 125GCX Mounting Plate ........................................................... 126GCX Vertical Wall Mount Arm ............................................ 127GCX Roll Stand .................................................................. 128Soft-Sided Carrying Case ................................................... 129

Performance Considerations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .131Overview ....................................................................................... 131Performance Considerations ........................................................ 132

Dysfunctional Hemoglobins ................................................ 132Anemia ............................................................................... 133Saturation ........................................................................... 133Pulse Rates ........................................................................ 133

OXIMAX Sensor Performance Considerations ............................. 133

Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .137Overview ....................................................................................... 137On-Screen Help ............................................................................ 138

Accessing Multiple Topics .................................................. 138Accessing Single Topics ..................................................... 141

Error Codes .................................................................................. 143Prompts and Error Messages ....................................................... 146Primary Speaker Failure ............................................................... 149Help and Support .......................................................................... 151EMI (Electromagnetic Interference) .............................................. 156Obtaining Technical Assistance .................................................... 157

Returning your Monitor ....................................................... 157

Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .159Overview ....................................................................................... 159Service .......................................................................................... 159Periodic Safety Checks ................................................................. 159Cleaning ........................................................................................ 160

Using SatSeconds . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .161Overview ....................................................................................... 161SatSeconds Safety Net .............................................................. 163SatSeconds Display ...................................................................... 163

Factory Default Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .165Overview ....................................................................................... 165Neonate Default Settings .............................................................. 165Adult Default Settings ................................................................... 166

N-600x Operators Manual v

Principles of Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 169Overview .......................................................................................169

Automatic Calibration ..........................................................170Functional versus Fractional Saturation .............................171Measured versus Calculated Saturation .............................172

OXIMAX Technology .....................................................................173Functional Testers and Patient Simulators ...................................174

Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 175Performance ..................................................................................175Electrical ........................................................................................176Environmental Conditions .............................................................178Physical Characteristics ................................................................180Compliance ...................................................................................180Manufacturers Declaration ...........................................................181

Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 195

Contents

vi

Safety Information

N-600x Operators Manual 1

S a f e t y I n f o r m a t i o n

Safety Warnings

Warnings are identified by the WARNING symbol shown above.

Warnings alert you to potential serious outcomes (death, injury, or adverse events) to the patient or user.

WARNING: The sensor extrapolates from the date and time provided by the N-600x when recording the sensor event record to the sensor. The accuracy of the date/time is determined by the date/time setting of the N-600x. It is recommended that the N-600x user set the time/date to the correct value before a sensor event record-enabled sensor is connected, and that this date/time not be changed while the sensor remains connected. Since a sensor with sensor event record data can be transported from one monitor to another, having discrepancies in the date/time between monitors and the sensor event record data will affect the order the sensor event record data appears. To eliminate this possible problem, all monitors within an institution should be set to the same time.

Safety Information

2 N-600x Operators Manual

WARNING: Explosion hazard. Do not use the N-600x pulse oximeter in the presence of flammable anesthetics or gases.

WARNING: Chemicals from a broken LCD display panel are toxic when ingested. Use caution when handling a pulse oximeter with a broken display panel.

WARNING: Pulse oximetry readings and pulse signals can be affected by certain environmental conditions, OXIMAX sensor application errors, and certain patient conditions. See the appropriate sections of this manual for specific safety information.

WARNING: The use of accessories, sensors, and cables other than those specified may result in increased emission and/or decreased immunity and inaccurate readings of the N-600x pulse oximeter.

WARNING: Failure to cover the OXIMAX sensor site with opaque material in high ambient light conditions may result in inaccurate measurements.

Safety Information


Safety Cautions

Cautions are identified by the CAUTION symbol shown above.

Cautions alert you to exercise care necessary for the safe and effective use of the N-600x pulse oximeter.

Caution: When connecting the N-600x to any instrument, verify proper operation before clinical use. Both the N-600x and the instrument connected to it must be connected to a grounded outlet. Accessory equipment connected to the pulse oximeters data interface must be certified according to IEC Standard 60950 for data-processing equipment or IEC Standard 60601-1 for electromedical equipment. All combinations of equipment must be in compliance with IEC Standard 60601-1-1 systems requirements. Anyone who connects additional equipment to the signal input port or signal output port (N-600x data port connector) configures a medical system and is therefore responsible for ensuring that the system complies with the requirements of system standard IEC Standard 60601-1-1 and the electromagnetic compatibility system standard IEC Standard 60601-1-2. The N-600x accuracy may degrade if it is connected to secondary I/O devices when the instrument is not connected to earth reference.

Caution: Federal law (U.S.A.) restricts this device to sale by or on the order of a physician.

Caution: Dispose of battery in accordance with local requirements and regulations.

Safety Information


Introduction


I n t r o d u c t i o n

WARNING: The N-600x is intended only as an adjunct in patient assessment. It must be used in conjunction with clinical signs and symptoms.

Intended Use

The N-600x pulse oximeter is indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. The N-600x is intended for use with neonatal, pediatric, and adult patients who are well or poorly perfused, in hospitals, hospital-type facilities, intra-hospital transport, and home environments. For prescription use only.

Note:Hospital use typically covers such areas as general care floors, operating rooms, special procedure areas, intensive and critical care areas, within the hospital plus hospital-type facilities. Hospital-type facilities include physician office based facilities, sleep labs, skilled nursing facilities, surgicenters, and sub-acute centers.

Intra-hospital transport includes transport of a patient within the hospital or hospital-type facility.

Note: Home Care use is defined as managed or used by a lay person (parent or other similar noncritical caregiver) in the home environment.

Use with any particular patient requires the selection of an appropriate oxygen OXIMAX sensor as described in this manual.

Introduction


How to Use this Manual

All users should read this manual thoroughly. More experienced users of the N-600x can directly go to the topics for the information they require.

This manual is available on the Internet at:

http://www.mallinckrodt.com/respiratory/resp/Serv_Supp/ProductManuals.html

Symbols, Controls, Displays and Indicators


S y m b o l s , C o n t r o l s , D i s p l a y s a n d I n d i c a t o r s

About the Front Panel

Figure 1: Front Panel Buttons and Symbols

1. SpO2 OXIMAX Sensor Port, page 26. 12. ADJUST UP Button, page 10.2. Low Battery Indicator, page 17. 13. ADJUST DOWN Button, page 10.3. AC Power Indicator, page 16. 14. Neonate Mode Indicator, page 18.4. ON/STANDBY Button, page 10. 15. HELP/CONTRAST Button, page 11.5. Battery Fuel Gauge Indicator, page 34. 16. Fast Response Mode Indicator, page 18.6. Waveform Display, page 12. 17. Softkeys, page 11.7. SatSecondsTM Indicator, page 18. 18. Menu Bar, page 11.8. %SpO2 Display, page 16. 19. Data In-Sensor Indicator, page 18.9. Pulse Rate Display, page 16. 20. Interference Indicator, page 17.10. Alarm Silence Indicator, page 17. 21. Pulse Search Indicator, page 17.11. ALARM SILENCE Button, page 10. 22. Monitor Speaker.



About the Rear Panel

Figure 2: Rear Panel Components

1. Equipotential Terminal (Ground).2. AC Power Connector, page 24.3. Data Port Connector, page 110.4. Fuse Holder.5. Supply Voltage Selector Switch, page 24.



About the Symbols

The symbols, located on the rear panel of the N-600x, are as follows.

Table 1: Symbols and Descriptions

Symbol Description

See Instructions for Use

Fuse Replacement

Equipotential Terminal (ground)

Date of Manufacture

Data Interface

Type BF Applied Part - Not defibrillator proof



About the Controls

ON/STANDBY Button Turns the monitor on and off.

Note: Pressing a button, except the ON/STANDBY button, should result in either a valid or an invalid key tone (refer to Table 3). If the key pressed fails to emit a tone, contact qualified service personnel.

WARNING: Pressing ALARM SILENCE will keep ALL alarms from sounding for the alarm silence duration period.

ALARM SILENCE Button Silences current alarms for the alarm silence duration period. When an alarm has been silenced, pressing the button again reactivates, or unsilences the alarm. It is also used to view and adjust alarm silence duration and alarm volume. The ALARM SILENCE button clears SENSOR OFF, LOW BATTERY, and SENSOR DISCONNECT messages from the display.

ADJUST UP Button Increases variable parameters of the monitor.

ADJUST DOWN Button Decreases variable parameters in the monitor.



HELP/CONTRAST Button Enables you to access the on-screen help and adjust the monitor screen contrast.

Pressing and releasing the HELP/CONTRAST button launches the on-screen help.

Pressing and holding the HELP/CONTRAST button while simultaneously pressing the ADJUST UP and ADJUST DOWN buttons lightens or darkens the display screen.

Softkey Menu BarDisplays the current functions for each of the four softkey buttons.

About the Displays

Pleth Display

The pleth display is user selectable. Refer to Selecting the Pleth View on page 50.



The pleth display includes a wiper bar plethysmographic waveform, menu bar, and current measured %SpO2 and pulse rate. If SatSeconds are enabled, the pleth display includes the SatSeconds indicator and SatSeconds setting. A decimal point after the %SpO2 or pulse rate indicates the respective limits have been changed from the power on defaults (Overview on page 71). Plethysmographic waveforms with peak to peak amplitudes less than ten PAUs are associated.

Caution: Verify the movement of the blip bar or plethys-mographic waveform or beating heart before accepting any displayed data as a current measurement.

When the monitor is powered by the internal battery, the pleth display includes a horizontal battery fuel gauge positioned in the upper left corner which shows the remaining charge (operating hours) on the battery. If a monitor reporting low battery is connected to an AC power source, the battery fuel gauge displays the charging progress. The battery fuel gauge is cleared from the display once the monitor can provide at least 15 minutes of operating time.

Blip Display

The blip display includes a pulse amplitude blip bar, current measured %SpO2 and pulse rate, and current upper and lower %SpO2 and pulse rate limits. If SatSeconds are enabled, the blip display includes the SatSeconds indicator and SatSeconds setting. Decimal points after the %SpO2 or pulse rate indicate that the respective limits have been changed from the power-on defaults.



When the monitor is powered by internal battery, the blip display includes a horizontal battery fuel gauge positioned in the upper left corner that shows the remaining charge (operating hours) on battery. If a monitor reporting a low battery is connected to AC power, the battery fuel gauge shows the charging progress. The battery fuel gauge is cleared from the display once the monitor can provide at least 15 minutes of operating time on battery.



Real-Time Trend Display

The real-time trend display includes %SpO2 and/or pulse rate trend data plots and current measured %SpO2 and pulse rates. The trend data plots are automatically updated as each new trend point is calculated, where the interval between calculations is based on the display time scale selected. If SatSeconds is enabled, the real-time trend display includes the SatSeconds indicator. Decimal points after the displayed %SpO2 or pulse rate indicate that the respective limits have been changed from the power-on defaults. Each time a pulse is detected by the oximeter, a heart icon flashes.

SpO2 and Pulse Rates

There are various matrixes within the N-600x algorithm. Some of these are used to assess the severity of conditions presented to the N-600x in measuring SpO2 and pulse rate on a patient. These individual matrices or combinations of these matrices are used to drive the LED indicators on the N-600x front panel.



The N-600x algorithm automatically extends the amount of data required for measuring SpO2 and pulse rate depending on the measurement conditions. During normal measurement conditions the averaging time is 6 to 7 seconds. During conditions such as those caused by low perfusion, interference (e.g., external interference like ambient light), or a combination of these, the N-600x algorithm automatically extends the amount of data required beyond 7 seconds. If the resulting dynamic averaging time exceeds 20 seconds, the pulse search indicator is lit solid and SpO2 and Pulse Rate will continue to be updated every second. As these conditions extend, the amount of data required continues to increase. If the dynamic averaging time reaches 40 seconds, the pulse search indicator begins flashing, the SpO2 and pulse rate displays flash zeros indicating a loss-of-pulse condition.

WARNING: Failure to cover the OXIMAX sensor site with opaque material in high ambient light conditions may result in inaccurate measurements.



About the Visual Indicators

Table 2: Visual Indicators

Indicator Description

%SpO2 Display Shows the hemoglobin oxygen saturation level. The display value flashes zeros during loss-of-pulse alarms and flashes the SpO2 value when the SpO2 is outside the alarm limits. During Pulse Search, the monitor continues to update the display. If alarm limits have been changed from their power-on defaults, a decimal point (.) is displayed after the SpO2 value (81.).

Pulse AmplitudeIndicator (blip bar)

Indicates pulse beat and shows the relative (non-normalized) pulse amplitude. As the detected pulse becomes stronger, more bars light with each pulse. This indicator is available only in the blip view.

PlethysmographicWaveform Display

Displays a non-normalized waveform in real-time sensor signals. The relative pulsatile strength and quality of the incoming signals can be observed.

Pulse Rate Display Displays the pulse rate in beats per minute. It flashes during loss-of-pulse alarms and when the pulse rate is outside of the alarm limits. During Pulse Search, the monitor continues to update the display. Pulse rates outside of the pulse rate range of 20 to 250 bpm are displayed as 0 and 250, respectively. If alarm limits have been changed from their power-on defaults, a decimal point (.) is displayed after the BPM value (112.).

AC PowerIndicator

Lights continuously when the N-600x is connected to an AC power source. The indicator shows that the battery is charging. It is off when the monitor is being powered by internal battery.



Low BatteryIndicator

Lights continuously when 15 or fewer minutes of battery capacity remain. Flashes when the battery capacity reaches a critically low condition.

Battery Fuel GaugeIndicator

Displays the battery charge remaining on the monitor. The battery fuel gauge consists of four bars, each corresponding to approximately 1.5 hours of operating time. All four bars are lit when the battery is fully charged. No bars are lit when a low battery condition exists. See Battery Fuel Gauge Indicator on page 34.

Alarm SilenceIndicator

Lights continuously when an audible alarm has been silenced. It flashes when the alarm silence duration has been set to Off.

InterferenceIndicator

Lights whenever the N-600x algorithm detects the incoming signal quality is degraded.

Note: Degradation can be caused by ambient light, electrical noise, electro-surgical interference, patient activity, or other causes.

An intermittently lit Interference Indicator is common during patient monitoring, and indicates the N-600x algorithm is dynamically adjusting the amount of data required for measuring SpO2 and Pulse Rate. When lit continuously, the N-600x algorithm has extended the amount of data required for measuring SpO2 and Pulse Rate and consequently fidelity in tracking rapid changes in these values may be reduced.

Pulse SearchIndicator

Lights continuously prior to initial acquisition of a pulse signal and during prolonged and challenging monitoring conditions. The pulse search indicator flashes during a loss-of-pulse signal.





Data In-SensorIndicator

Lights to indicate that the attached OXIMAX sensor contains a patient sensor event record. The sensor event record information may be viewed or printed.

SatSecondsIndicator

Fills in clockwise as the SatSeconds alarm management system detects a %SpO2 reading outside of the limit setting. Empties in counterclockwise direction when %SpO2 reading is within limits. When the indicator is full, a medium priority alarm sounds.

Fast ResponseMode Indicator

Determines the response time (2 to 4 seconds in fast mode and 5 to 7 seconds in normal mode) applied by the OXIMAX algorithm in its calculation of SpO2. The OXIMAX algorithms calculation of pulse rate is unaffected by the response mode setting. The trending interval (2 seconds or 4 seconds) updated automatically by the monitor to roughly correspond with the SpO2 calculation response time.

Neonate AlarmLimits Indicator

Displays when the alarm limits are set to neonate. No symbol displays when the monitor is set to adult limits.





About the Audible Indicators


Table 3: Audible Indicators

Function Description

Alarm Silence Reminder

Three beeps sound approximately every three minutes when alarms are silenced with the alarm silence duration set to OFF and the alarm silence reminder function is enabled.

Confirmation Tone Three beeps sound to indicate default settings have been saved or reset to factory defaults or trend data has been deleted.

Invalid Button Press Short, low-pitched tone indicating a button has been pressed that is inappropriate for the current state of the monitor.

Valid Button Press Short, medium-pitched tone indicating an appropriate button has been pressed.

High Priority Alarm High-pitched, fast-pulsing tone indicating loss-of-pulse.

Note: If a High Priority Alarm is not silenced within 30 seconds by pressing the ALARM SILENCE Key, the monitor increases the urgency level of the audible alarm signal by alternating a piezo tone with the primary alarm tone. See Piezo Tone on page 20.

Medium Priority Alarm

Medium-pitched, pulsing tone indicating an SpO2 or pulse rate limit violation.

Note: If a Medium Priority Alarm is not silenced within 2 minutes by pressing the ALARM SILENCE Key, the monitor increases the urgency level of the audible alarm signal by alternating a piezo tone with the primary alarm tone. See Piezo Tone on page 20.



Low Priority Alarm Low-pitched, slow-pulsing tone indicating an OXIMAX sensor disconnect, low battery, or monitor failure.

Note: If a Low Priority Alarm is not silenced within 2 minutes by pressing the ALARM SILENCE Key, the monitor increases the urgency level of the audible alarm signal by alternating a piezo tone with the primary alarm tone. See Piezo Tone on page 20.

Piezo Tone A high-pitched piezo tone is sounded if there is no user response to an audible alarm, or if the monitor detects a failure of the primary speaker. See High, Medium, and Low Priority Alarms in Table 3.

Power-On Self-Test Pass

One-second tone indicating the monitor has been turned on and has successfully completed the power-on self-test.

Pulse Beep Single beep sounds for each detected pulse. The pitch of the pulse beep signal changes with a point-by-point rise or fall in the saturation level.

Volume Setting Tone Continuous tone used when adjusting the alarm volume.

Table 3: Audible Indicators

Function Description

Setting Up the Monitor


S e t t i n g U p t h e M o n i t o r

WARNING: To ensure patient safety, do not place the pulse oximeter in any position that might cause it to fall on the patient.

WARNING: As with all medical equipment, carefully route patient cabling to reduce the possibility of patient entanglement or strangulation.

WARNING: Ensure that the speaker is clear of any obstruction. Failure to do so could result in an inaudible alarm tone.

WARNING: Disconnect the N-600x and Nellcor OXIMAX sensor from the patient during magnetic resonance imaging (MRI) scanning. Objects containing metal can become dangerous projectiles when subjected to the strong magnetic fields created by MRI equipment. Also, induced currents could potentially cause burns.

WARNING: To ensure accurate performance and prevent device failure, do not subject the N-600x to extreme moisture, such as direct exposure to rain. Such exposure may cause inaccurate performance or device failure.

WARNING: Do not use an N-600x pulse oximeter, OXIMAX sensor, cables, or connectors that appear damaged.



WARNING: Do not lift the pulse oximeter by the pulse oximetry cable or power cord because the cable or cord could disconnect from the pulse oximeter, causing the pulse oximeter to drop on the patient.

WARNING: The N-600x is not defibrillator-proof. However, it may remain attached to the patient during defibrillation or while an electrosurgical unit is in use, but the readings may be inaccurate during the defibrillation and shortly thereafter.

WARNING: In the USA, do not connect the pulse oximeter to an electrical outlet controlled by a wall switch, because the pulse oximeter may be accidentally turned off.

WARNING: Use only the Nellcor pulse oximetry cable DOC-10 with the N-600x pulse oximeter. Use of another pulse oximetry cable will have an adverse effect on performance. Do not attach any cable that is intended for computer use to the OXIMAX sensor port. Do not connect any device other than a Nellcor-approved OXIMAX sensor to the OXIMAX sensor connector.

WARNING: The N-600x should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the N-600x should be observed to verify normal operation in the configuration it is to be used.

Note: The monitor incorporates watchdog timers which reset the monitor in the event of software errors.



List of Components

Quantity Item

1 N-600x Pulse Oximeter

1 Nellcor OXIMAX Sensor or Assortment Pack

1 DOC-10 Pulse Oximetry Cable

1 N-600x Operators Manual (applicable to country of sale) and/or compact disc

1 Power Cord (applicable to country of sale)

2 Fuses, 0.5 A, 250 volts, slow-blow, IEC (5 x 20 mm)

1 Quick Guide



Connecting to an AC Power Source

WARNING: In the USA, do not connect the pulse oximeter to an electrical outlet controlled by a wall switch, because the pulse oximeter may be accidentally turned off.

Caution: The Supply Voltage Selector switch must be set to the correct voltage (115 or 230) to avoid equipment damage and ensure battery charging.

Caution: Use only the hospital-grade power cord provided by Nellcor.

1. Set the Supply Voltage Selector switch to the applicable voltage.

2. Plug the female connector end of the power cord into the power connector on the rear of the monitor.

3. Plug the male connector of the power cord into a properly grounded AC outlet.



Caution: Ensure the pulse oximeter is properly grounded when operating on AC power. If you are uncertain whether the AC outlet is properly grounded, disconnect the pulse oximeter from the outlet and use the battery power. Contact a qualified electrician to examine the outlet for ground connections.

4. Verify the monitors AC power indicator is lit.

Note: If the AC power indicator is not lit, check the:

power cord

supply voltage selector switch

user-accessible fuses

AC power outlet

Note: The monitor can be operated with a depleted battery when connected to an AC power outlet. A warning message displays and must be cleared by pressing the ALARM SILENCE button before the monitor can be used for patient monitoring.



Connecting an OXIMAX Sensor

The OXIMAX sensor type is shown at the bottom of the display when an OXIMAX sensor is connected to the N-600x or when the monitor completes POST with an OXIMAX sensor attached.

Note: Sensor LED light emissions fall within Class 1 level, according to IEC 60825-1:2001.

Caution: Use only Nellcor-approved OXIMAX sensors and pulse oximetry cables.

Note:Physiological conditions, medical procedures, or external agents that may interfere with the monitors ability to detect and display measurements include dysfunctional hemoglobin, arterial dyes, low perfusion, dark pigment, and externally applied coloring agents, such as nail polish, dye, or pigmented cream.

1. Firmly connect a DOC-10 pulse oximetry cable to the SpO2 OXIMAX Sensor Port of the monitor.

2. Connect a Nellcor OXIMAX SpO2 sensor to the opposite end of the DOC-10 pulse oximetry cable.

Operating the Battery


O p e r a t i n g t h e B a t t e r y

WARNING: Dispose of battery in accordance with local requirements and regulations.

Operating on Battery Power

The N-600x monitor has an internal battery that can be used to power the monitor during transport or when AC power is not available. A new, fully charged battery provides at least 7 hours of monitoring time under the following conditions:

No audible alarms sound

No analog or serial output devices are attached to the N-600x

Default display brightness setting

The monitor cannot be used when the battery is depleted unless the monitor is connected to an AC power source. A warning message displays and must be cleared by pressing the ALARM SILENCE button before the monitor can be used for patient monitoring.

The pleth and blip displays include a battery fuel gauge indicator that shows the remaining charge (operating hours). When the monitor is fully charged, all four bars are lit on the indicator.

Caution: If the N-600x monitor is stored for a period of three months or longer, notify service personnel to place the monitor in "Shelf-mode" prior to storage. The monitor can be placed in "Shelf-mode" by qualified service personnel using the procedures indicated in the N-600x Service Manual. Recharge the battery when it has not been charged for three or more months.



Caution: Replace the battery if fewer than four bars are lit after fully charging the battery. To charge a low or fully depleted battery, connect the monitor to AC power outlet. A full charge of a fully depleted battery takes 8 hours to charge while the monitor is turned off. A full charge of a fully depleted battery takes 12 hours while the monitor is in the normal operating mode.

Caution: If the monitor is operated on an AC power source with a depleted battery and the AC power is subsequently lost, the monitor will shut down immediately.

When all of the following conditions are present for 15 minutes, the N-600x automatically shuts down:

Monitor is running on battery power

No buttons have been pressed

No pulse has been detected (for example, when a patient is not connected to the OXIMAX sensor or the OXIMAX sensor is disconnected from the monitor)

No alarms are present (other than low battery or a non-correctable error)

Note:Whenever the monitor is connected to AC power source, the battery is being charged. We recommend the monitor remain connected to an AC power source when not in use. This ensures a fully-charged battery when the monitor is needed.



Low Battery Indicator

The Low Battery Indicator lights and a low priority alarm begins to sound when approximately 15 minutes of monitoring time is available on the existing battery charge. Refer to Table 4 for a description of the low and critical battery conditions.

A low battery audible alarm can be cancelled by pressing the ALARM SILENCE button. The low battery indicator and display screen message continues to display. Connecting the monitor to an AC power source silences the audible alarm, but the low battery indicator remains lit as long as the battery is in the low voltage condition. After the 15-minute period of low battery condition, a high priority alarm sounds for about 10 seconds before the monitor shuts off.

If the monitor backlight is turned off during a low battery condition, the backlight cannot be turned back on.

Nellcor recommends that a qualified service personnel replace the internal battery every 24 months. Replaced batteries should be disposed of in accordance with local ordinances.

Caution: The pulse oximeter default settings will return to factory default setting if the battery becomes fully discharged or is replaced. Qualified service personnel will have to reset the institutional defaults, following the instructions in the N-600x Service Manual.

Note: If the AC voltage selector switch on the monitor rear panel does not match your AC voltage source, the monitor may run on battery power, even though it is connected to an AC power source, which eventually results in a low priority alarm and a lighted low battery indicator. Ensure that the switch setting matches your AC voltage.

Note: As the battery is used and recharged over time, the amount of time between the onset of the low battery alarm and the instrument shut-off may become shorter.



Description of Low and Critical Battery Conditions

Table 4: Low and Critical Battery Conditions

State Critical BatteryLow Battery

AC Power Operation

1 No No Yes SpO2-normal

AC/Battery charge LED-on

LOW BATTERY LED-off

LOW BATTERY message-off

Audible alarm-off

Error code-none

Effect of ALARM SILENCE key-normal

Shutdown-N/A

2 No No No SpO2-normal

AC/Battery charge LED-off

LOW BATTERY LED-off


Audible alarm-off

Error code-none

Effect of ALARM SILENCE key-normal

Shutdown- N/A



3 No Yes No SpO2-normal


LOW BATTERY LED-on

LOW BATTERY message-on

Audible alarm-low priority

Error code-logged

Effect of ALARM SILENCE key-First press silences audio alarm, second press cancels LOW BATTERY message (LED) stays on until Low Battery Condition is corrected.

Shutdown-Imminent

4 No Yes Yes SpO2-normal

AC/Battery charge LED-on

LOW BATTERY LED-on


Audible alarm-off

Error code-logged

Effect of ALARM SILENCE key-N/A (LED stays on)

Shutdown-N/A

Note: Connecting AC functions the same as ALARM SILENCE key in state 3.


AC Power Operation



5 Not used

6 Yes Yes No SpO2-not displayed


LOW BATTERY LED-on (flashing)

LOW BATTERY message-on

Audible alarm-high priority

Error code-displayed and logged

Effect of ALARM SILENCE key-none

Shutdown-after 10 seconds


AC Power Operation



7 Yes Yes Yes SpO2 - displayed.

AC/Battery Charge LED - on

LOW BATTERY LED-on (flashing)

LOW BATTERY message - on

The Battery Fuel Gauge Indicator shows a fully depleted battery (no bars lit).

Warning message in the pleth window: UNIT WILL SHUT DOWN IF AC POWER LOST

Audio alarm - low priority

Error code - logged

Affect of Silence key - One press silences the audible alarm. Pressing the Affect Silence key twice cancels the LOW BATTERY message, removes the warning message and restores default Pleth (or Blip) display (LED continues to FLASH until Low Battery condition is not true, Battery Fuel Gauge Indicator shows charging progress)

Shutdown - N/A


AC Power Operation



Battery Fuel Gauge Indicator

The N-600x has a battery fuel gauge indicator which displays the battery power remaining on the monitor. The indicator appears on the the pleth and blip display screens. When the monitor is fully charged, all four bars are lit on the battery fuel gauge indicator. The battery fuel gauge indicator capacities are described below.

Note: The levels in Table 5 are based on a brand new battery. As a battery is used and recharged over time, it may provide only 75% of the capacity of brand new battery. For example, a battery that is two-years old may provide only 75% (3 bars) of the capacity of a new battery.

Caution: If the battery is fully depleted, and the AC power is lost, the monitor will shut down.

Table 5: Battery Fuel Gauge Indicator Levels

Level Description

Indicates 100% battery capacity remaining.





Using the Monitor


U s i n g t h e M o n i t o r

Overview

This section describes menu navigation, power on/off and display options, parameter ranges, OXIMAX sensor attachments, and configuring default settings suitable for your environment.

Menu Description

The N-600x is outlined below. You can choose the type of trend data to view by selecting either Monitor trend or Sensor trend data in the Trend menu. Sensor sub-menu choices differ depending on what type of in-sensor data is stored in the sensor chip, such as, event or loop.

The menu structure includes BACK softkey options that enable you to move back to the previous menu level without exiting the Trend menu entirely. Trend data must be compiled on entry/reentry to the Trends menu. When the softkeys are available, both BACK and EXIT options are available. The BACK softkey goes to the previous level and the EXIT softkey goes to the main menu. If only one space is available the BACK softkey is included, this may require going back one or two levels to get to an EXIT softkey.

The BACK and EXIT softkeys are positioned on the right-most softkeys, respectively. The below menu structure identifies:

BOLDFACE TYPE softkey title as displayed on the monitor

Underlined Text description of the softkey menu item

Italicized Text the destination of the BACK and EXIT softkeys

Using the Monitor


Menu Structure

Main MenuLIMITS (Limits Menu)- SELECT- NEO- ADULT

EXIT (to Main menu)TREND (Trend Menu)- MON (Monitor Menu)- - VIEW (Monitor Trend View Menu)- - - DUAL- - - SPO2- - - PULSE- - - NEXT (History/Amplitude Menu)- - - - HIST (Delete/Print2 Menu)- - - - - DELETE (Delete Trends)- - - - - - DELETE TRENDS- - - - - - - YES (return to Main menu)- - - - - - - NO (back to Delete/Print menu)- - - - - PRINT- - - - - BACK (back to Hist/Amp menu)- - - - - EXIT (to Main menu)- - - - AMP (Amplitude Menu)- - - - - BACK (back to Hist/Amp menu)- - - - - EXIT (to Main menu)- - - - BACK (back to Monitor Trend View menu)- - - - EXIT (to Main menu)- - ZOOM (Monitor Trend Zoom Menu)- - - TIME (Cycle through 48h, 36h, 24h, 12h, 8h, 4h, 2h,

1h, 30m, 15m, 40s, 20s for current view)- - - SCALE (Cycle through 5, 10, 15, 20, 25, 30,

35, 40 and 50 (units of BPM or %SpO2, depending on the data displayed) of the max and min. values under the cursor, default to 10 to 100 for SAT trend graph and 5-250 for Pulse trend graph if there is no data point under the cursor for current view)

- - - AUTO (Based on all of the graphed trend data: maximum value, rounded up to nearest multiple of 10, minimum value, rounded down to nearest multiple of 10 minus 10)

- - - BACK (back to Monitor menu)

Using the Monitor


Menu Structure (continued...)

- - NEXT (Delete/Print1 Menu)- - - DELETE- - - - DELETE TRENDS?- - - - - YES (to Main menu)- - - - - NO (back to Delete/Print1 menu)- - - PRINT- - - BACK (back to Monitor menu)- - - EXIT (to Main menu)- - BACK (back to Trend menu)- SENSOR (Sensor/Event Menu)

(if Event data is in the sensor, the following menu, the Screen will remain in the appropriate state until the next menu selection is made)

- - GRAPH (Graph Menu) (display events #1-N, in inverse chronological order; up/down also scroll through events in order)

- - - < (show previous graph, only available when there is a previous graph)

- - - > (show next graph, only available when there is a next graph)

- - - PRINT- - - BACK (back to Sensor menu)- - TABLE (Table Menu)- - - ^ (show previous table, only available when there is a

previous graph; bottom/top line repeats in new table)

- - - v (show next table, only available when there is a next graph; bottom/top line repeats in new table)

- - - PRINT- - - BACK (back to Sensor menu)- - BACK (back to Trend menu)- - - EXIT (to Main menu)

(Sensor/Loop Menu) (If continuous-Loop data is in the sensor, the following will be displayed)

- - VIEW (Sensor Trend View Menu)- - - DUAL (shows SPO2+BPM)- - - SPO2- - - PULSE- - ZOOM (cycle through 2h, 1h, 30m, and 15m for current

view)

Using the Monitor



- - PRINT- - BACK (to Trend menu)- EXIT (to Main menu)SETUP (Setup Monitor Menu)- VIEW (Setup View Menu)- - PLETH- - BLIP

- TREND- - - VIEW (RT Trend View Menu)- - - - DUAL- - - - SPO2- - - - PULSE- - - - BACK- - - ZOOM (RT Trend View Menu)- - - - TIME- - - - SCALE- - - - AUTO- - - - BACK- - BACK (back to Setup menu)- - EXIT (to Main menu)- - - SENSOR (Setup Sensor Menu)- - DATA (On-screen options for SENSOR-R (Write-once

Sensor) sensor are: SPO2, SPO2+BPM, DEFAULT. On-screen options for SENSOR-RW (rewritable sensor) are: SPO2, SPO2+BPM, DEFAULT. SELECT toggles SENSOR-R or SENSOR-RW sensor type; up/down keys scroll through options in order.) The SENSOR-R feature supports all of the current OXIMAX sensors.

- - - SELECT- - - BACK (back to Setup Sensor menu)- - - EXIT (to Main menu)- - MSG (Sensor Set Message Menu)- - - BACK (back to Setup Sensor menu)- - - EXIT (to Main menu)- NEXT (Clock/Language Menu)- - CLOCK (Clock Menu)- - - SET (Clock Set Menu)- - - - SELECT (press select to toggle through hours,

minutes, seconds, month, day, year; use up/down buttons to set each selection)

Using the Monitor



- - - - BACK (back to Clock/Language menu)- - - - EXIT (to Main menu)- - - BACK (back to Clock/Language menu)- - - EXIT (to Main menu)- - LANG (Language Setup Menu) (use up/down buttons to

toggle though languages)- - - BACK (back to Clock/Language menu)- - NEXT (Communication/Nurse Call Menu)- - - COMM (Communication Port Configuration Menu)- - - - SELECT- - - - BACK (back to Communication/Language menu)- - - - EXIT (to Main menu)- - - NCALL Nurse Call Menu)- - - - NORM +- - - - NORM -- - - - BACK (back to Communication/Nurse Call menu)- - - - EXIT (to Main menu)- - - NEXT (Analog/Mode Menu)- - - - ANALOG (Analog Voltage Select Menu)- - - - - 0 VOLT- - - - - 1 VOLT- - - - - STEP- - - - - BACK (back to Analog/Mode menu)- - - - MODE (Mode Menu)- - - - - BACK (back to Analog/Mode menu)- - - - - EXIT (to Main menu)- - - - BACK (back to Communication/Nurse Call menu)- - - - EXIT (to Main menu)- - - BACK (back to Clock/Language menu)- - BACK (back to Setup menu)- EXIT (to Main menu)LIGHT (Light Menu)- OFF (Turns display backlight off)- EXIT (to Main menu)

Using the Monitor


Parameter Ranges

The parameters of the N-600x monitor are preset to factory default settings. See Factory Default Settings on page 165. The factory default parameters may be changed to institutional default parameters by following the procedures in the N-600x Service Manual.

Table 6 lists the parameters, ranges available, and the factory default setting. The parameters may be set on an individual basis, by the clinician, and these settings remain in effect until the monitor is turned off.

Table 6: Parameter Ranges

Parameter Ranges/SelectionsFactory Adult Defaults

Factory Neonate Defaults

%SpO2 Upper Alarm Limit

Lower Alarm Limit plus 1 to 100%

100% 95%

%SpO2 Lower Alarm Limit

20% to Upper Alarm Limit minus 1

85% 85%

Pulse Rate Upper Alarm Limit

Lower Alarm Limit plus 1 to 250 bpm

170 bpm 190 bpm

Pulse Rate Lower Alarm Limit

30 bpm to Upper Alarm Limit minus 1

40 bpm 90 bpm

Alarm Silence Duration

Alarms 30, 60, 90, 120 seconds

60 60

Alarm Volume

1 to 10 7 7

Alarms Allow Off - Yes/No

Off Reminder - Yes/No

No

Yes

No

Yes

Using the Monitor


Backlight Brightness

0 to 10

Data Port Baud Rate

2400, 9600, 19200

9600 9600

Data Port Mode

ASCII, GRAPH, OXINET, CLINICAL, PHILIPS, MARQ (GE Marquette), DATEX (Datex-Ohmeda)

ASCII ASCII

Default Display Format

Pleth, BlipReal-Time Trend

Pleth Pleth

Display Contrast

Low to high Medium Medium

Language English, Danish, Dutch, Finnish, French, German, Norwegian, Portuguese, Spanish, Italian, Swedish

English English

Limits Adult, Neonate Adult Neonate

On AC Power

10 10

On Battery Power

8 8

Pulse Beep Volume

0 to 10 4 4

Pulse Rate Lower Alarm Limit

30 bpm to Upper Alarm Limit minus 1

40 bpm 90 bpm




Using the Monitor


Pulse Rate Upper Alarm Limit

Lower Alarm Limit plus 1 to 250 bpm

170 bpm 190 bpm

Real-Time Trend Display

Saturation, Dual, Pulse Rate

Saturation Saturation

Real-Time Trend Scale

48, 36, 24, 12, 8, 4, 2, 1 hours, 30 minutes

30 minutes 30 minutes

Response Mode

Normal or Fast Normal Normal

RS-232 Level Nurse Call Polarity

Normally High, Normally Low

Normally Low Normally Low

SatSeconds Off, 10, 25, 50, 100

Off Off

Allow SatSeconds

Yes/No Yes Yes

Sensor Event Date Format (SENSOR-R and SENSOR-RW

SpO2, SpO2+Pulse Rate, Default (default is factory default)

Default Default

Sensor Messages Enabled

Yes/No Yes Yes

Trend Display

Dual, %SpO2, Pulse, Histogram, Amplitude

%SpO2 %SpO2

Trend Scale 48, 36, 24, 12, 8, 4, 2, 1 hours, 30, 15 minutes, 40, 20 seconds

2 hours 2 hours




Using the Monitor


Turning On the Monitor

Before using the monitor in a clinical setting, verify the monitor is safe and working properly. Proper working condition is verified each time the N-600x is turned on as described in the following procedure.

Caution: If any indicator or display element does not light when the pulse oximeter is turned on, do not use the pulse oximeter. Instead, contact qualified service personnel, your local Nellcor representative, or Nellcors Technical Services Department.

Note: Physiological conditions, medical procedures, or external agents that may interfere with the monitors ability to detect and display measurements, include dysfunctional hemoglobin, arterial dyes, low perfusion, dark pigment, and externally applied coloring agents such as nail polish, dye, or pigmented cream.

Note: The monitor automatically launches the Power-On Self-Test (POST), which tests the monitor circuitry and functions.

Caution: During POST (immediately after power-up), confirm that all indicators light, all display segments turn on, and the pulse oximeter speaker sounds a sequence of three ascending tones. After the POST process complete, verify that a single one-second tone sounds.

1. Turn on the monitor by pressing the ON/STANDBY button.

2. Ensure all of the front panel indicators illuminate.

Using the Monitor


3. Once the display test portion of POST completes, the software version displays for approximately five seconds and a sequence of three ascending tones sound.

Note:The software version shown above is only a sample. Check your monitor for the current software version installed.

The software version is often needed when calling Nellcors Technical Services Department or your local Nellcor representative for technical assistance. Record the software version number and have it available prior to contacting technical assistance.

4. If the monitor detects an internal problem during the POST process, an error tone sounds and the monitor displays an error code (EEE) and the corresponding number (see Troubleshooting on page 137).

5. Upon successful completion of the POST, the monitor sounds a one-second tone indicating the monitor has passed the test.

Using the Monitor


WARNING: If you do not hear the POST pass tone, do not use the pulse oximeter.

WARNING: Ensure the speaker is clear of any obstructions. Failure to do so could result in an inaudible alarm tone.

Note:In addition to serving as the POST pass verification, the POST pass tone also functions as an audible confirmation that the speaker is performing properly. If the speaker does not function, the alarm warning sounds cannot be heard.

OXIMAX Sensor Attached

WARNING: Do not use any other cables to extend the length of the DOC-10 Pulse Oximetry Cable. Increasing the length of the DOC-10 cable will degrade signal quality and may lead to inaccurate measurements.

When an OXIMAX sensor is connected to the monitor, a SENSOR TYPE: . . . message is displayed 4 to 6 seconds at the bottom of the monitor display. The message identifies the type (model) of OXIMAX sensor connected to the monitor. The type is used to determine the action messages in the OXIMAX sensor message(s) function. This display is the first message displayed when an OXIMAX sensor is connected to the monitor.

Using the Monitor


For a sensor containing data, the message identifies the sensor data type. For a blank sensor, the message identifies the monitors current data type setting used to write data to the sensor. The data type settings are SpO2 and SPO2+BPM.

Note:The type of data recorded is only displayed when data is present in the OXIMAX sensor.

The monitor displays zeros in the %SpO2 and Pulse Rate displays while the N-600x is searching for a valid pulse. For optimal performance, allow the monitor to search and lock onto a pulse for approximately 5 to 10 seconds.

When a valid pulse is detected, the monitor enters the Monitoring Mode and displays patient parameters.

Using the Monitor


Notice the movement of the blip bar or plethysmographic waveform or beating heart indicating the monitor is displaying real-time data. Listen for the pulse beep tone. If the pulse beep tone does not sound with each pulse, it is an indication the pulse beep volume is set to zero, the speaker is malfunctioning, or the signal is corrupt.

When an OXIMAX sensor is attached to the monitor and applied to a patient, the monitor may lose a pulse signal. If a pulse signal is lost, an alarm sounds and a poor signal condition message displays on the monitor screen. At this point, the monitor displays [--- / ---] (3 dashes / 3 dashes) and remains in the Pulse Search Mode for five seconds before displaying the poor signal condition screen. The poor signal condition screen is part of the N-600x's Sensor Messages feature. For more information about OXIMAX Sensor Messages, refer OXIMAX Sensor Messages on page 68.

Using the Monitor


No OXIMAX Sensor Attached

Upon successful completion of the POST process, the monitor sounds a one-second tone indicating that the monitor has passed the POST.

or

The monitor displays dashes [ - - - ] and the Pulse Search indicator is not lit, indicating the monitor failed to detect an OXIMAX sensor.

Using the Monitor


Turning the Backlight On or Off

You can turn off the backlight by pressing the LIGHT softkey and then pressing OFF.

Note: Any of the following conditions turn on the backlight:

pressing any of the softkeys

pressing and holding the HELP/CONTRAST button

pressing the ALARM SILENCE button

any alarm

Adjusting the Screen Contrast

1. With the monitor in the normal monitoring mode, press and hold the HELP/CONTRAST button while pressing the ADJUST UP or ADJUST DOWN button until the desired contrast is obtained.

2. Press the HELP/CONTRAST button to return to the normal monitoring mode.

Adjusting the Backlight Brightness

1. With the monitor in the normal monitoring mode, press the LIGHT softkey.

2. Press the ADJUST UP or ADJUST DOWN button until the desired backlight brightness is obtained.

Using the Monitor


Selecting the Pleth View

The pleth view displays the pleth waveform, %SpO2, and pulse rate data. Refer to Principles of Operation on page 169, for a description of the pleth waveform.

1. With the monitor in the normal monitoring mode, press the SETUP softkey.

2. Press the VIEW softkey.

3. Press the PLETH softkey. The pleth view displays.

Selecting the Blip View

The blip view displays the SpO2, pulse rate, blip bar, and limits in a larger format for easier viewing.



Using the Monitor


3. Press the BLIP softkey. The blip view displays.

Selecting the Real-Time Trend View

The real-time trend view displays the %SpO2 and/or pulse rate trend data. The real-time trend submenu enables you to:

select the trend data display,

set the trend time scale display, and

set the trend amplitude scale display.



3. Press the TREND softkey. The real-time trend view displays.

Using the Monitor


Selecting the Trend Data Display

1. Press the SETUP softkey.


3. Press the TREND softkey.


5. Press any of the trend softkeys (DUAL, SPO2, or PULSE).

Setting the Trend Time Scale Display




4. Press the ZOOM softkey.

5. Press the TIME softkey to cycle the displayed trend time scale through 48 hours, 36 hours, 24 hours, 12 hours, 8 hours, 4 hours, 2 hours, 1 hour, and 30 minutes.

Using the Monitor


Setting the Trend Amplitude Scale Display




4. Press the ZOOM softkey.

5. Press the SCALE softkey to cycle the trend amplitude scale display through 5 points, 10 points, 15 points, 20 points, 25 points, 30 points, 35 points, 40 points and 50 points above and below the newest - rightmost - trend data point.

Note: You can set the trend amplitude scale to AUTO by pressing the AUTO softkey. The maximum trend data point is rounded up to the nearest multiple of 10, shown at the top of the graph display. The minimum trend data point is rounded down to the next multiple of 10. 10 is then subtracted from the rounded down number. This value is located at the bottom of the trend graph.

Setting the Pulse Beep Volume

With the monitor in the normal monitoring mode, press and hold the ADJUST UP or ADJUST DOWN button to increase or decrease the pulse beep volume.

Using the Monitor


Setting the Alarm Volume

The Alarm Volume display enables you to adjust the volume of alarm tones.

1. With the monitor in the normal monitoring mode, press the ALARM SILENCE button until the alarm volume level displays and sounds on the monitor.

2. While continuing to press the ALARM SILENCE button, press and hold the ADJUST UP or ADJUST DOWN button to increase or decrease the volume.

Using the Monitor


Setting the Date and Time

WARNING: The sensor extrapolates from the date and time provided by the N-600x when recording the sensor event record to the sensor. The accuracy of the date/time is the responsibility of the N-600x. It is recommended that the N-600x user set the time/date to the correct value before a sensor event record-enabled sensor is connected, and that this date/time not be changed while the sensor remains connected. Since a sensor with sensor event record data can be transported from one monitor to another, having discrepancies in the date/time between monitors and the sensor event record data will affect the order the sensor event record data appears. To eliminate this possible problem, all monitors within an institution should be set to the same time.


2. Press the NEXT softkey.

3. Press the CLOCK softkey.

4. Press the SET softkey.

Using the Monitor


5. Press the SELECT softkey to select the TIME and DATE fields as shown in the graphic below.

TIME HOURS : MINUTES : SECONDS (16 : 46 : 05)

DATE DAY - MONTH - YEAR (02 - JAN - 06)

6. Use the ADJUST UP or ADJUST DOWN buttons to change the selected value.

7. Press the EXIT softkey.

Using the Monitor


Setting the Alarm Silence Duration

The Alarm Silence Duration display enables you to adjust the alarm silence duration.

1. With the monitor in the normal monitoring mode, press the ALARM SILENCE button until the alarm silence duration setting displays. The alarm silence durations available are 30, 60, 90, and 120 seconds.

2. Press and hold the ALARM SILENCE button and the ADJUST UP button to increase the alarm silence duration setting.

3. Press and hold the ALARM SILENCE button and the ADJUST DOWN button to decrease the alarm silence duration setting.

Note: Releasing the ADJUST UP or ADJUST DOWN button sets the alarm silence duration.

Using the Monitor


Disabling Audible Alarms

Setting the alarm silence duration to OFF disables all audible alarms.

Note: The ability to set the alarm silence duration to OFF can be enabled or disabled by qualified service personnel as described in the N-600x Service Manual.

The N-600x Service Manual is available on the Internet at:

http://www.mallinckrodt.com/respiratory/resp/Serv_SuppProductManuals.html

WARNING: Do not disable the audible alarm function or decrease the audible alarm volume if the patients safety could be compromised.


1. With the monitor in the normal monitoring mode, press the ALARM SILENCE button until the alarm silence duration setting displays.

Using the Monitor


2. While pressing the ALARM SILENCE button, press and hold the ADJUST UP button until OFF displays. Release the buttons.

Selecting the Standby Mode

The standby mode enables the monitor to retain the alarm limit settings that are in effect while monitoring a patient. The monitor must be connected to an AC power source to enter the standby mode.

Normally, the standby mode setting is used when a patient has to temporarily leave the monitor.

1. Verify the N-600x is monitoring a patient and the alarm limits are configured to the patient being monitored.

2. Disconnect the sensor from the monitor.

3. Press the ALARM SILENCE button to silence the audible alarms.

Using the Monitor


4. Press the ALARM SILENCE button to disable the alarm messages.

The monitor is now in the standby mode. Reconnect the sensor to the monitor and the patient to return to normal monitoring.

Adult-Pediatric or Neonatal Settings

The clinician can set the monitors operating mode to adult-pediatric or neonatal by using the LIMITS softkey. This setting remains active until the monitor is turned OFF. The factory default power-on setting is for adult-pediatric patients. This default setting can be changed to neonatal by qualified service personnel using the procedures indicated in the N-600x Service Manual.

Refer to Table 15, for neonate factory default limit settings. Refer to Table 16, for adult factory default limit settings.

WARNING: Each time the pulse oximeter is used, check alarm limits to ensure that they are appropriate for the patient being monitored.

Using the Monitor


Setting Patient Adult-Pediatric or Neonatal Modes

1. With the monitor in the normal monitoring mode, press the LIMITS softkey. The monitor displays the ADULT LIMITS or NEONATE LIMITS screen, depending on the patient setting used.

2. Press the NEO or ADULT softkey to select ADULT LIMITS or NEONATE LIMITS depending on the patient being monitored.

EXITSELECT

%SP02

BPM

---

NEONATE LIMITS%SPO2

UPPERLOWER

BPM9585

19090

SAT-S NEO ADULT100

NEO

100

---

Using the Monitor


Alarm Limit Changed Indicator

Alarm limits that have been changed from the institution or factory default settings are identified by a decimal point (.) after the displayed reading (%SpO2 or BPM). The changed parameter is also identified by a decimal point on the alarm limits screen.

Setting Alarm Limits

The Alarm Limit display enables you to adjust the upper and lower saturation and pulse rate limits. It also enables you to adjust the SatSeconds limit.

The Alarm Limit display is accessed by pressing the LIMITS softkey on the main menu.

The Alarm Limit display includes the alarm limit table and current measured %SpO2 and pulse rate. The title of the alarm limit table indicates whether the instrument is in Adult or Neonate monitoring mode. If SatSeconds are enabled, the Alarm Limit display also includes the SatSeconds indicator. Decimal points after the displayed %SpO2 or pulse rate indicate that the respective limits have been changed from the power-on defaults.

Using the Monitor


1. Press the LIMITS softkey. The current alarm limits display.

2. Press the ADULT or NEO softkey to select the Adult-Pediatric or Neonatal alarm limits screen.

3. Press the SELECT softkey to select the parameter to be adjusted.

4. Use the ADJUST UP or ADJUST DOWN buttons to increase or decrease the selected limit parameter.

5. Repeat steps 2, 3, and 4 as necessary to complete the alarm limits setup.

EXITSELECT

%SP02

BPM

---

NEONATE LIMITS%SPO2

UPPERLOWER

BPM9585

19090

SAT-S NEO ADULT100

NEO

100

---

OR

Using the Monitor


6. Wait for the display to time-out to accept the changes or press the EXIT softkey to close the display and return to the normal monitoring mode.

Note: Limit changes are in effect as long as the monitor remains turned on. When the monitor is turned off, the institutional default limits are restored. When the monitor is turned on, the institutional default limits are effected. Factory or institutional defaults are selected by qualified service personnel by following the procedures outlined in the N-600x Service Manual.

Setting SatSeconds Alarm Limit

Refer to Using SatSeconds on page 161, for more information on the SatSeconds feature.

Note: The ability to adjust the SatSeconds Alarm limit can be enabled or disabled by a qualified service personnel as described in the N-600x Service Manual.

1. With the monitor in the normal monitoring mode, press the LIMITS softkey. The current alarm limits display.

2. Press the SELECT softkey twice to select %SpO2 SAT-S.

3. Use the ADJUST UP or ADJUST DOWN buttons to select the limit. The choices are 10, 25, 50, 100 seconds or OFF.

4. Press the EXIT softkey to save your selection.

Using the Monitor


Setting Monitor Response Mode

The purpose of the response mode is to set the response time of the N-600x algorithm calculation of the SpO2 (the response mode does not affect the N-600x algorithms calculation of pulse rate). The trending interval (2- or 4-seconds) is updated automatically by the monitor to roughly correspond with the SpO2 calculation response time.

The response mode automatically programs the N-600x algorithm to record and display monitor trend information at 2-second intervals (Fast Mode) up to 24 hours or 4-second intervals (Normal Mode) up to 48 hours.

The response mode display screen includes the current SpO2 response mode setting and the current measured %SpO2 and pulse rate. When in the fast mode, the screen displays the fast mode symbol.


2. Press the NEXT softkey three times.

Using the Monitor


3. Press the MODE softkey.

Note: When the monitor is in the fast response mode, the monitor may produce more SpO2 and pulse rate alarms than you are accustomed to experiencing.

4. Use the ADJUST UP or ADJUST DOWN buttons to select the desired response mode.


Using the Monitor


Selecting the Display Language

The N-600x can be programmed to display the information in various languages. The languages available are:

ENGLISH DANSK (Danish) DEUTSCH (German)ESPAOL (Spanish) FRANCAIS (French)ITALIANO (Italian)NEDERLANDS (Dutch)NORSK (Norwegian)PORTUG (Portuguese)SUOMI (Finnish)SVERIGE (Swedish)


2. Press the NEXT softkey.

3. Press the LANG softkey.

Using the Monitor


4. Use the ADJUST UP or ADJUST DOWN buttons to select the desired language.


Note: The selected language displays until the monitor is turned OFF. The selected language can be set as a default by qualified service personnel by following the procedures outlined in the N-600x Service Manual.

OXIMAX Sensor Messages

OXIMAX sensor messages consist of sensor adjust condition messages and sensor adjust messages which, when enabled, are displayed when the monitor is not able to display saturation. When OXIMAX sensor messages are displayed, it is an indication that the OXIMAX sensor is functioning properly, but the site to which the OXIMAX sensor applies or the application method is not optimal for calculating %SpO2. Condition messages are followed by action messages. Up to three condition messages may be displayed on the POOR SIGNAL CONDITION display in priority order, highest on top. The condition display may be dismissed by using the EXIT softkey. Once closed, the OXIMAX sensor message screen will not return until a new condition occurs.

Using the Monitor


If the HELP softkey is pressed from the Condition message display, the action messages are displayed. Action messages are linked to the sensor type; action messages will be displayed for the type of OXIMAX sensor connected to the monitor. Up to five action messages may be displayed. Multiple screens may be required to display all of the messages. When multiple screens are required, navigation between screens can be accomplished by using the NEXT, BACK, and EXIT softkeys.

OXIMAX sensor messages may be disabled. Refer to OXIMAX Sensor Messages on page 68 for selecting the OXIMAX Sensor Messages, Enable/Disable function.

OXIMAX Sensor Adjust Condition Messages

Condition SENSOR OFF?

Condition SMALL PULSES

Condition WEAK SIGNAL

Condition INTERFERENCE

Condition EXCESS INFRARED LIGHT

Condition INTERFERENCE

Condition HIGH PULSE AMPLITUDE

Using the Monitor


OXIMAX Sensor Adjust Messages

Message ALTERNATE SITE?

Message COVER SENSOR SITE?

Message EAR/FOREHEAD SENSOR?

Message NASAL/EAR SENSOR?

Message OXIMAX ADHESIVE SENSOR

Message SECURE CABLE

Message HEADBAND

Message WARM SITE

Message BANDAGE ASSEMBLY

Message NAIL POLISH

Message SENSOR TOO TIGHT?

Message REPOSITION SENSOR

Message ISOLATE INTERFERENCE SOURCE

Message CLEAN SENSOR SITE

Using Monitor Trend Data


U s i n g M o n i t o r T r e n d D a t a

Overview

The trend displays enable you to view trend data. Two types of trend data can be viewed:

Monitor trend data stored in the monitor

Patient event data stored in the OXIMAX sensor (single-patient-use OXIMAX sensors only) and can be used with the sensor event record feature.

Monitor trend data can be viewed anytime patient trend is stored in the monitor. Monitor trend displays are accessed by pressing the TREND softkey on the main menu and selecting the MONITR softkey option. The monitor trend submenu enables you to choose which trend data are displayed:

Saturation and pulse rate (Dual)

Saturation

Pulse rate

Pulse amplitude

Histogram

The N-600x can graphically display trend data for SpO2, pulse rate, or both. Trend data is stored at 2- or 4-second intervals and linked to the response mode. When the TREND softkey is pressed, READING TRENDS displays at the bottom of the N-600x screen, indicating that the monitor is formatting the trend data to be displayed.



The monitor stores up to 48 hours of 4-second trend data or 24 hours of 2-second trend data. The amount of trend data displayed on the screen is determined by using the ZOOM softkey. The settings available are 20 and 40 seconds, 15 or 30 minutes, and 1, 2, 4, 8, 12, 24, 36, or 48 hours. All trend data are displayed in a graphical format except the 20 and 40 second trend displays, which are shown in tabular format.

The trend display can be viewed throughout the 48 hours of trend data. Selecting the 1-hour trend display allows you to view one hour of trend information. By using the scrolling feature, any one hour of trend data can be viewed up the 48 hours of trend information. The ADJUST DOWN button scrolls the display to the left and the ADJUST UP button scrolls the display to the right.

When the data displays, the most recent readings are on the right side of the graph. The numbers below %SpO2 indicate the highest and lowest parameter values at the cursor position (vertical dotted line on the display). See Table 7.

Trend data is further explained in Specifications on page 175.

Trend data information may be retrieved through the N-600x data port or cleared using options available in a display menu.

Caution: Monitor trend data will be lost if the main battery fails or is removed.



Storing Trend Data

Whenever the N-600x is turned on, it stores the monitor %SpO2 and pulse rate readings in memory every 2- or 4-seconds (regardless of whether the N-600x is monitoring a patient or not). The N-600x can store up to 48 hours of 4-second trend data or 24 hours of 2-second trend data. The 48/24 hours of stored trend data can be downloaded to a printer or a portable computer. Up to 50 alarm limit changes can be stored in the trend data. If more than 50 alarm limit changes occur during the 48/24 hours of trend data collection, the additional alarm limit changes will take space reserved for trend data.

Caution: Changing alarm limit settings uses up trend memory space. Change alarm limits only as needed.

Note: Trend memory always contains the most recent 48 hours of data, with newly collected data overwriting the oldest data on a rolling basis. The N-600x continues to record data points as long as the monitor is powered on, with blank data points collected if no OXIMAX sensor is connected to the monitor or patient. Blank data overwrites older patient data if the memory becomes full. Therefore, if you want to save old patient data, it is important that you turn your monitor off when you are not monitoring a patient, and that you download the trend memory before it fills up and overwrites the old data with new data (or blank data).



OXIMAX Sensor Type

When an OXIMAX sensor is connected to the monitor, a SENSOR TYPE:... message is displayed for 4 to 6 seconds at the bottom of the display. The message identifies the type (model) of OXIMAX sensor connected to the monitor. Type is used in the determination of action messages in the OXIMAX sensor message(s) function. This display is the first message displayed when an OXIMAX sensor is connected to the monitor.

Selecting the Trend Data Display Scale

The trend scale is the amount of trend data displayed on the screen.

1. With the monitor in the normal monitoring mode, press the TREND softkey.

2. Press the MONITR softkey.


4. Press any of the trend softkeys (DUAL, SPO2, or PULSE). To select HIST (histogram) or AMP (amplitude), press the NEXT softkey and then the HIST or AMP softkeys.



5. Press the ZOOM softkey. The Zoom menu displays.

Pressing the TIME softkey cycles the displayed trend time scale through 48 hours, 36 hours, 12 hours, 8 hours, 4 hours, 2 hours, 1 hour, 30 minutes, 15 minutes, 40 seconds and 20 seconds.

Note: The 20-second and 40-second trend displays are in tabular format. The display below begins in the normal response mode (left side of the display) and switches to the fast response mode.

Pressing the SCALE softkey cycles the displayed trend amplitude scale through 5 points, 10 points, 15 points, 20 points, 25 points, 30 points, 35 points, 40 po

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